FDA Says Biosimilar Sponsors Should Include Reference Product on Labeling

Biosimilar sponsors need to include the name of the reference product in labeling if the label includes clinical data derived from that product, the FDA said in a final guidance released Wednesday.

Sponsors should include the biosimilar’s proprietary name in cases where the information in a section of the labeling is specific to the biosimilar product itself, such as the sections on description, indications and usage, dosage and administration, and storage and handling, the agency said.

The proprietary name should also be used in sections that cover risks and warnings of adverse events, such as boxed warnings, contraindications and the “drug interactions” section.